Treatment of Pulmonary SUlcus, Pancoast and Chest Wall Non-small Cell Lung Cancer Employing Radiation, Immuno-oncology and Resection

Sponsor
Marc de Perrot
Study ID
NCT06331455
Phase
PHASE2
Status
Recruiting
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Conditions

  • Lung Cancer Patients
  • Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Two doses of durvalumab (1500 mg IV)
  • Non-ablative oligofractionated radiation (NORT) — RADIATION
    12 Gy of Radiation in 3 fractions

Study Details

The SUPER trial is a prospective Phase II trial. It is designed for patients with stage 2 or 3 non-small cell lung cancer (NSCLC) prior to surgery. Patients who are enrolled in this trial will receive combination of Non-ablative oligofractionated radiation (NORT) and two cycles of Durvalumab, an immunotherapy drug before their surgery.

Key Dates

Start date
May 22, 2024
Status verified
Jul 2024
Primary completion
Dec 31, 2025
Completion
Apr 30, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant NORT-Durvalumab
    administration of non-ablative oligofractionated radiation therapy using 12 Gy in 3 fractions in combination with two doses of durvalumab (1500 mg IV) prior to surgery.

Primary Outcome Measure

To Measure CD8 TILs density & Major Pathological Response (MPR) [ Time Frame: 5-6 weeks post treatment ]

Central Contacts

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